Proposed change to acceptance criteria for dissolution performance verification testing

Pharmacopeial Forum

Volumn 33, Issue 3, 2007, Pages 574-579

  Hauck, Walter W ^a   Manning, Ronald G ^a   Cecil, Todd L ^a   Brown, William ^a   Williams, Roger L ^a  

^a UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PREDNISONE; SALICYLIC ACID;

ACCURACY; ARTICLE; CONTROLLED STUDY; DRUG MANUFACTURE; DRUG SOLUBILITY; PERFORMANCE; QUALITY CONTROL; RELIABILITY; REPRODUCIBILITY; SAMPLE SIZE; STANDARDIZATION; TABLET; TABLET MANUFACTURE; UNITED STATES;

EID: 40949129355     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Article

References (5)

1. USP Council of Experts Biopharmaceutics Expert Committee, Dissolution Advisory Panel, and USP Staff. The USP performance verification test part 1: proficiency testing and the USP dissolution procedure. Submitted for publication. 2007.
2. Glasgow M, Dressman S, Brown W, et al. The USP performance verification test, part II: collaborative study of USPs Lot P Prednisone Tablets. J Pharm Sci. In press.
3. ISO. Guide 43-I, Proficiency Testing by Interlaboratory Comparisons - Development and Operation of Proficiency Testing Schemes. 2nd ed. Geneva, Switzerland: ISO; 1997.
4. ISO. Guide 5725-6, Accuracy (Trueness and Precision) of Measurement Methods and Results - Use in Practice of Accuracy Values. Geneva, Switzerland: ISO; 1994.
5. ISO. Technical Specification 21748, Guidance for the Use of Repeatability, Reproducibility, and Trueness Estimates in Measurement Uncertainty Estimation. Geneva, Switzerland: ISO; 2004.